RecruitingNot ApplicableNCT06073067

GRID Therapy for Extremity Soft Tissue Sarcoma

Safety, Efficacy, and Mechanism of Pre-operative Spatially Fractionated GRID Radiation Therapy in Patients With Extremity Soft Tissue Sarcoma: A Pilot Study


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

20 participants

Start Date

Nov 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with extremity soft tissue sarcoma (STS) are at high risk of recurrence. Pre-operative radiotherapy is used to increase the safe removal of tumors and improve local control in these patients. Increasing the preoperative radiotherapy dose with standard techniques might lead to normal tissue toxicity and postoperative wound complications. GRID radiation therapy is a technique that may increases radiation dose with minimal added toxicity. It is hypothesized that GRID radiation dose will improve tumor response without increasing post-operative wound complications. While GRID has been used in many patients, there have been few formal studies to evaluate the safety and efficacy of the technique. In this study, a single priming dose of GRID will be administered to subjects with high-risk extremity soft tissue sarcoma prior to standard radiotherapy and tumor resection to determine the safety and clinical efficacy of the GRID dose. This single-arm pilot study will assess the safety of spatially fractionated grid radiation therapy (GRID) on 20 subjects with resectable extremity soft tissue sarcoma, followed by standard-of-care conventional radiotherapy (XRT) and tumor resection.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests GRID therapy — a specialized pattern of radiation delivery — for people with soft tissue sarcoma in the limbs (arms or legs) that is too large for standard treatment approaches. GRID therapy delivers high doses of radiation to large tumors in a way that may be more effective and better tolerated. **You may be eligible if...** - You are 18 or older - You have confirmed soft tissue sarcoma in a limb (arm or leg) - Your tumor is large and you are being treated before surgery (neoadjuvant setting) - You are in adequate overall health (ECOG 0–2) - You have normal blood, liver, and kidney function for radiation treatment **You may NOT be eligible if...** - You have received prior radiation to the same area - You have certain genetic conditions that increase radiation sensitivity - You have serious organ problems or a very poor health status - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONGRID therapy

GRID therapy delivers a high dose of radiation to small areas of tumor interleaved with areas that intentionally receive a low dose


Locations(1)

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, United States

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NCT06073067


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